Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis
Introduction Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofaci...
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| creator | Clowse, Megan E. B. Feldman, Steven R. Isaacs, John D. Kimball, Alexandra B. Strand, Vibeke Warren, Richard B. Xibillé, Daniel Chen, Yan Frazier, Donald Geier, Jamie Proulx, James Marren, Amy |
| description | Introduction
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.
Objective
The objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.
Methods
Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.
Results
Out of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy,
n
= 1), seven spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 3), and eight medical terminations (monotherapy,
n
= 4; combination therapy,
n
= 3; blinded therapy,
n
= 1) were identified. Remaining cases reported healthy newborns (
n
= 25) or were pending/lost to follow-up (
n
= 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy,
n
= 43; combination therapy,
n
= 1), including five spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 1), 23 healthy newborns, and 16 pending/lost to follow-up.
Conclusions
The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored. |
| doi_str_mv | 10.1007/s40264-016-0431-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4933738</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1827910909</sourcerecordid><originalsourceid>FETCH-LOGICAL-c503t-13d510e621bfed0b790300331b08cfc8b9264a9639315209cc9b92f4114383713</originalsourceid><addsrcrecordid>eNp1kU1LJDEQhsOyyzo76w_wIoG9eGmtSvorlwXR_RAExdWjhHQ6PROZTtwkLYy_fjOMii54Kqh66q16eQnZQzhEgOYolsDqsgCsCyg5Fo8fyAyxEQWKkn0kM0Asi0pgvUO-xHgHAC2r289khzWsZSVrZ-T2MpiFU06v6cWUtB9NpNbRtDT02g9K22Sd7egfNZi0pqcqqU7FzAw-0KulmUaVvO3pcUjLkNlIlevpZfTBqmjjV_JpUKtodp_qnNz8_HF98rs4v_h1dnJ8XugKeCqQ9xWCqRl2g-mhawRwAM6xg1YPuu1EtqlEzQXHioHQWuTWUGZ7vOUN8jn5vtW9n7rR9Nq4FNRK3gc7qrCWXln5duLsUi78gywF503WmJODJ4Hg_04mJjnaqM1qpZzxU5TYskYgCBAZ_fYfeuen4LK9DZW_46yqMoVbSgcfYzDDyzMIchOe3IYnc3hyE558zDv7r128bDynlQG2BWIeuYUJr06_q_oPVQelHw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1822093255</pqid></control><display><type>article</type><title>Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Clowse, Megan E. B. ; Feldman, Steven R. ; Isaacs, John D. ; Kimball, Alexandra B. ; Strand, Vibeke ; Warren, Richard B. ; Xibillé, Daniel ; Chen, Yan ; Frazier, Donald ; Geier, Jamie ; Proulx, James ; Marren, Amy</creator><creatorcontrib>Clowse, Megan E. B. ; Feldman, Steven R. ; Isaacs, John D. ; Kimball, Alexandra B. ; Strand, Vibeke ; Warren, Richard B. ; Xibillé, Daniel ; Chen, Yan ; Frazier, Donald ; Geier, Jamie ; Proulx, James ; Marren, Amy</creatorcontrib><description>Introduction
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.
Objective
The objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.
Methods
Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.
Results
Out of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy,
n
= 1), seven spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 3), and eight medical terminations (monotherapy,
n
= 4; combination therapy,
n
= 3; blinded therapy,
n
= 1) were identified. Remaining cases reported healthy newborns (
n
= 25) or were pending/lost to follow-up (
n
= 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy,
n
= 43; combination therapy,
n
= 1), including five spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 1), 23 healthy newborns, and 16 pending/lost to follow-up.
Conclusions
The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-016-0431-z</identifier><identifier>PMID: 27282428</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject><![CDATA[Abortion ; Adult ; Antirheumatic Agents - administration & dosage ; Antirheumatic Agents - adverse effects ; Arthritis, Rheumatoid - complications ; Arthritis, Rheumatoid - drug therapy ; Birth weight ; Databases, Factual ; Drug Safety and Pharmacovigilance ; Drug Therapy, Combination ; FDA approval ; Female ; Females ; Follow-Up Studies ; Funding ; Humans ; Infant, Newborn ; Medicine ; Medicine & Public Health ; Methotrexate - administration & dosage ; Original ; Original Research Article ; Patients ; Pharmaceutical industry ; Pharmacology/Toxicology ; Piperidines - administration & dosage ; Piperidines - adverse effects ; Pregnancy ; Pregnancy Outcome ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Psoriasis ; Psoriasis - complications ; Psoriasis - drug therapy ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Randomized Controlled Trials as Topic ; Rheumatoid arthritis ; Studies ; Young Adult]]></subject><ispartof>Drug safety, 2016-08, Vol.39 (8), p.755-762</ispartof><rights>The Author(s) 2016</rights><rights>Copyright Springer Science & Business Media Aug 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-13d510e621bfed0b790300331b08cfc8b9264a9639315209cc9b92f4114383713</citedby><cites>FETCH-LOGICAL-c503t-13d510e621bfed0b790300331b08cfc8b9264a9639315209cc9b92f4114383713</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-016-0431-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-016-0431-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27282428$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Clowse, Megan E. B.</creatorcontrib><creatorcontrib>Feldman, Steven R.</creatorcontrib><creatorcontrib>Isaacs, John D.</creatorcontrib><creatorcontrib>Kimball, Alexandra B.</creatorcontrib><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Warren, Richard B.</creatorcontrib><creatorcontrib>Xibillé, Daniel</creatorcontrib><creatorcontrib>Chen, Yan</creatorcontrib><creatorcontrib>Frazier, Donald</creatorcontrib><creatorcontrib>Geier, Jamie</creatorcontrib><creatorcontrib>Proulx, James</creatorcontrib><creatorcontrib>Marren, Amy</creatorcontrib><title>Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Introduction
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.
Objective
The objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.
Methods
Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.
Results
Out of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy,
n
= 1), seven spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 3), and eight medical terminations (monotherapy,
n
= 4; combination therapy,
n
= 3; blinded therapy,
n
= 1) were identified. Remaining cases reported healthy newborns (
n
= 25) or were pending/lost to follow-up (
n
= 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy,
n
= 43; combination therapy,
n
= 1), including five spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 1), 23 healthy newborns, and 16 pending/lost to follow-up.
Conclusions
The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored.</description><subject>Abortion</subject><subject>Adult</subject><subject>Antirheumatic Agents - administration & dosage</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Arthritis, Rheumatoid - complications</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Birth weight</subject><subject>Databases, Factual</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug Therapy, Combination</subject><subject>FDA approval</subject><subject>Female</subject><subject>Females</subject><subject>Follow-Up Studies</subject><subject>Funding</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Methotrexate - administration & dosage</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology/Toxicology</subject><subject>Piperidines - administration & dosage</subject><subject>Piperidines - adverse effects</subject><subject>Pregnancy</subject><subject>Pregnancy Outcome</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Psoriasis</subject><subject>Psoriasis - complications</subject><subject>Psoriasis - drug therapy</subject><subject>Pyrimidines - administration & dosage</subject><subject>Pyrimidines - adverse effects</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rheumatoid arthritis</subject><subject>Studies</subject><subject>Young Adult</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kU1LJDEQhsOyyzo76w_wIoG9eGmtSvorlwXR_RAExdWjhHQ6PROZTtwkLYy_fjOMii54Kqh66q16eQnZQzhEgOYolsDqsgCsCyg5Fo8fyAyxEQWKkn0kM0Asi0pgvUO-xHgHAC2r289khzWsZSVrZ-T2MpiFU06v6cWUtB9NpNbRtDT02g9K22Sd7egfNZi0pqcqqU7FzAw-0KulmUaVvO3pcUjLkNlIlevpZfTBqmjjV_JpUKtodp_qnNz8_HF98rs4v_h1dnJ8XugKeCqQ9xWCqRl2g-mhawRwAM6xg1YPuu1EtqlEzQXHioHQWuTWUGZ7vOUN8jn5vtW9n7rR9Nq4FNRK3gc7qrCWXln5duLsUi78gywF503WmJODJ4Hg_04mJjnaqM1qpZzxU5TYskYgCBAZ_fYfeuen4LK9DZW_46yqMoVbSgcfYzDDyzMIchOe3IYnc3hyE558zDv7r128bDynlQG2BWIeuYUJr06_q_oPVQelHw</recordid><startdate>20160801</startdate><enddate>20160801</enddate><creator>Clowse, Megan E. B.</creator><creator>Feldman, Steven R.</creator><creator>Isaacs, John D.</creator><creator>Kimball, Alexandra B.</creator><creator>Strand, Vibeke</creator><creator>Warren, Richard B.</creator><creator>Xibillé, Daniel</creator><creator>Chen, Yan</creator><creator>Frazier, Donald</creator><creator>Geier, Jamie</creator><creator>Proulx, James</creator><creator>Marren, Amy</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U2</scope><scope>5PM</scope></search><sort><creationdate>20160801</creationdate><title>Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis</title><author>Clowse, Megan E. B. ; Feldman, Steven R. ; Isaacs, John D. ; Kimball, Alexandra B. ; Strand, Vibeke ; Warren, Richard B. ; Xibillé, Daniel ; Chen, Yan ; Frazier, Donald ; Geier, Jamie ; Proulx, James ; Marren, Amy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-13d510e621bfed0b790300331b08cfc8b9264a9639315209cc9b92f4114383713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Abortion</topic><topic>Adult</topic><topic>Antirheumatic Agents - administration & dosage</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Arthritis, Rheumatoid - complications</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Birth weight</topic><topic>Databases, Factual</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug Therapy, Combination</topic><topic>FDA approval</topic><topic>Female</topic><topic>Females</topic><topic>Follow-Up Studies</topic><topic>Funding</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Methotrexate - administration & dosage</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Patients</topic><topic>Pharmaceutical industry</topic><topic>Pharmacology/Toxicology</topic><topic>Piperidines - administration & dosage</topic><topic>Piperidines - adverse effects</topic><topic>Pregnancy</topic><topic>Pregnancy Outcome</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Psoriasis</topic><topic>Psoriasis - complications</topic><topic>Psoriasis - drug therapy</topic><topic>Pyrimidines - administration & dosage</topic><topic>Pyrimidines - adverse effects</topic><topic>Pyrroles - administration & dosage</topic><topic>Pyrroles - adverse effects</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Rheumatoid arthritis</topic><topic>Studies</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Clowse, Megan E. B.</creatorcontrib><creatorcontrib>Feldman, Steven R.</creatorcontrib><creatorcontrib>Isaacs, John D.</creatorcontrib><creatorcontrib>Kimball, Alexandra B.</creatorcontrib><creatorcontrib>Strand, Vibeke</creatorcontrib><creatorcontrib>Warren, Richard B.</creatorcontrib><creatorcontrib>Xibillé, Daniel</creatorcontrib><creatorcontrib>Chen, Yan</creatorcontrib><creatorcontrib>Frazier, Donald</creatorcontrib><creatorcontrib>Geier, Jamie</creatorcontrib><creatorcontrib>Proulx, James</creatorcontrib><creatorcontrib>Marren, Amy</creatorcontrib><collection>Springer Nature OA/Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Safety Science and Risk</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Clowse, Megan E. B.</au><au>Feldman, Steven R.</au><au>Isaacs, John D.</au><au>Kimball, Alexandra B.</au><au>Strand, Vibeke</au><au>Warren, Richard B.</au><au>Xibillé, Daniel</au><au>Chen, Yan</au><au>Frazier, Donald</au><au>Geier, Jamie</au><au>Proulx, James</au><au>Marren, Amy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>39</volume><issue>8</issue><spage>755</spage><epage>762</epage><pages>755-762</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Introduction
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.
Objective
The objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.
Methods
Pregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.
Results
Out of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy,
n
= 1), seven spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 3), and eight medical terminations (monotherapy,
n
= 4; combination therapy,
n
= 3; blinded therapy,
n
= 1) were identified. Remaining cases reported healthy newborns (
n
= 25) or were pending/lost to follow-up (
n
= 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy,
n
= 43; combination therapy,
n
= 1), including five spontaneous abortions (monotherapy,
n
= 4; combination therapy,
n
= 1), 23 healthy newborns, and 16 pending/lost to follow-up.
Conclusions
The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>27282428</pmid><doi>10.1007/s40264-016-0431-z</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Drug safety, 2016-08, Vol.39 (8), p.755-762 |
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| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Abortion Adult Antirheumatic Agents - administration & dosage Antirheumatic Agents - adverse effects Arthritis, Rheumatoid - complications Arthritis, Rheumatoid - drug therapy Birth weight Databases, Factual Drug Safety and Pharmacovigilance Drug Therapy, Combination FDA approval Female Females Follow-Up Studies Funding Humans Infant, Newborn Medicine Medicine & Public Health Methotrexate - administration & dosage Original Original Research Article Patients Pharmaceutical industry Pharmacology/Toxicology Piperidines - administration & dosage Piperidines - adverse effects Pregnancy Pregnancy Outcome Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Psoriasis Psoriasis - complications Psoriasis - drug therapy Pyrimidines - administration & dosage Pyrimidines - adverse effects Pyrroles - administration & dosage Pyrroles - adverse effects Randomized Controlled Trials as Topic Rheumatoid arthritis Studies Young Adult |
| title | Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis |
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